BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4102227 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-00479
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE USED ANOTHER SYRINGE TO INFLATE THE BALLOON. BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS AN ADD'L CASE ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA 3500A FORM HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE LUER CONNECTOR OF THE INFLATION PORT PRESENTED AN ISSUE. THE PROBLEM OCCURRED WHILE TRYING TO INFLATE THE BALLOON AND THE BALLOON DID NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577014 FLEXI-SEAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES, 78 KNT KNT CONVATEC, INC 411100 13VM507072

    Patients

    Seq Age Sex Outcome Treatment
    1